India Mandates Equal Treatment for Medical Devices, Challenging USFDA Preference
India’s drug regulator is pushing back against a perceived bias towards internationally certified medical devices, aiming to bolster the domestic industry and ensure equitable access to healthcare.
India’s apex drug regulator has directed hospitals nationwide to cease discriminating against medical devices that lack certification from the U.S. Food and Drug Governance (USFDA). The move follows mounting concerns that many healthcare facilities have been prioritizing imported products – particularly cardiac and orthopaedic implants – over locally manufactured alternatives. These critical implants,used in life-threatening conditions and for a range of musculoskeletal issues,are already subject to national price controls to maintain affordability across the country.
The directive, issued in a letter to state authorities earlier this week and reviewed by India Today, comes in response to repeated complaints that procurement agencies, including hospitals, were making US or European regulatory approval a prerequisite for bidding on contracts.
CDSCO Reasserts Authority on Device Approvals
In the letter, Drug Controller General of India Rajeev Singh Raghuvanshi emphasized that approval from the Central Drugs Standard Control Organisation (CDSCO) – granted after rigorous evaluation of safety and efficacy – is the sole mandated requirement for importing, manufacturing, selling, and distributing medical devices within India. Hospitals and state procurement bodies, the letter stated, should not exclude manufacturers whose devices are certified for the Indian market, even if they haven’t secured licensing abroad.
“This is a important step towards leveling the playing field for Indian medical device manufacturers,” said one industry analyst. “For too long, a perception of superior quality associated with USFDA approval has unfairly disadvantaged domestic companies.”
Historical Bias Against Indian Manufacturers
Industry insiders have long noted a tendency among government hospitals to favor foreign-made devices, a practise that has consistently hindered the growth of Indian manufacturers. While some state-level directives favoring imports have been rescinded following protests – gujarat being a notable example – the bias frequently enough persists at the hospital level.
“In many cases, foreign medical device makers exert influence on doctors or authorities, promoting the idea that USFDA approval is a hallmark of superior quality,” explained Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AiMeD), while welcoming the regulator’s latest stance. “Any public procurement should be based strictly on CDSCO licensing, not overseas approvals.”
India currently imports approximately $8 billion worth of medical devices annually,representing roughly two-thirds of the total domestic market.This highlights the nation’s continued reliance on foreign equipment and underscores the potential for growth within the indian medical device sector.
Concerns Remain Despite New Advisory
Despite the new advisory, local manufacturers caution that challenges remain. While foreign companies operating in India must obtain CDSCO approval, many Indian firms that do not target Western markets avoid pursuing USFDA or EU certification due to the ample compliance costs involved. Previous advisories have affirmed that Indian licensing is sufficient for quality assurance, yet reports indicate that hospitals in states like Gujarat and Uttar Pradesh continue to demand USFDA clearance.
A particularly concerning clause in the new DCGI letter states that “any other requirement should be above or over the requirement for a DCGI license.” AiMeD members fear this wording could allow hospitals to continue insisting on foreign certifications in addition to Indian approval.
ravi Rathod, a senior member of the association, warned that the situation on the ground may not change if buyers continue to perceive overseas approvals as a higher standard. AiMeD plans to formally request that the CDSCO remove what it deems an “unnecessary and confusing” remark. The institution believes a clearer directive is needed to ensure the regulator’s intent is fully realized and that Indian manufacturers receive a fair opportunity to compete for public contracts.
